Atellica CH Vanc 11097511Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414596020), received between Nov 22, 2019 and Nov 22, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Low Test Results” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2019Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED VANCOMYCIN (VANC) RESULT WAS OBTAINED USING ATELLICA CH 930 MODULE. THE INITIAL RESULT WAS OBTAINED WHILE THE QUALITY CONTROL (QC) WAS OUTSIDE OF RANGES AND WERE REPORTED TO THE PHYSICIAN(S). THE INITIAL RESULT WAS FLAGGED BY THE ATELLICA CH 930 MODULE. THE SAMPLE WAS REPEATED USING ANOTHER ATELLICA CH 930 MODULE. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9365627 ↗